Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used with the Superion Indirect Decompression System IFU, Superion IDS Kit IFU, Surgical Technique Manual
Recall
- Recall Number
- Z-1972-2023
- Event Number
- 92181
- Firm
- Boston Scientific Neuromodulation Corporation
- FEI Number
- 3006630150
- Product Code
- NQO
- Status
- Open, Classified
- Root Cause
- Labeling design
- Initiated
- May 12, 2023
- Posted
- June 15, 2023
- Address
- 25155 Rye Canyon Loop, Valencia, CA, 91355-5004
Description
Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used with the Superion Indirect Decompression System IFU, Superion IDS Kit IFU, Surgical Technique Manual
Pending update to indirect decompression system instructions for use informing users that excessive force during the implant procedure may cause driver instrument tip breaks, which may result in metal fragments (Driver teeth/tips) within the implant location; and if metal fragments are not removed and remain in situ, MRI scans are NOT advised due to potential risk of patient injury.
On 05/12/23, correction notices were mailed to physicians/surgeons, hospitals, healthcare professionals who were advised the following: IFU advises against forced deployment, as it could result in device breakage. Correction notice advises to review of the IFUs/Surgical Technique Manual. Avoid application of excessive force, use only two or three fingers when performing final tightening during device deployment). Inspect Driver instrument prior to/following use; if Driver tip break is noted: Retrieve metal fragment(s), consider performing imaging. Missing/bent teeth prevents Driver engagement with implant and requires exchange for a new/replacement Driver instrument to complete successful deployment. If metal fragment(s) are not successfully removed: MRI scans are NOT advised, Append the patient s medical record with a copy of this letter to maintain awareness of metal fragment(s) remaining in situ for the remaining service life of the device. Consider alternative imaging for patients with metal fragment(s) remaining in situ, e.g., X-ray/ultrasound/CT scan. Distributors asked to notify all customers that have been shipped/sold affected product. Complete/return acknowledgement form to [email protected] or Fax to: Field Action Center (1-866-213-1806). Driver tip breakage can be identified via an audible click, a loss of tactile resistance during the implant procedure, and/or visual detection following removal of the Driver instrument from the inserter tool and subsequent inspection. Adverse events or quality concerns should be reported to [email protected]. If you have any question, contact Senior Management Quality: at 651-581-0761 or email: [email protected] Firm is updating IFU to advise against MRI scanning for patients with unretrieved metal fragments. A separate letter was sent to health care professions providing them with a patient letter. Patient letter states firm recommends patients discuss this letter with t
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